Taclonex Scalp (Calcipotriene and Betamethasone Dipropionate Topical Suspension)
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Taclonex Scalp (Calcipotriene and Betamethasone Dipropionate Topical Suspension)

TACLONEX®
(calcipotriene and betamethasone dipropionate)

DRUG DESCRIPTION

Taclonex® Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is intended for topical use only.

Calcipotriene hydrate is a synthetic vitamin D3 analog. Chemically, calcipotriene hydrate is 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol,24-cyclo-propyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3,H20, a molecular weight of 430.6, and the following structural formula:

Calcipotriene hydrate Structural Formula Illustration

Calcipotriene hydrate is a white to almost white, crystalline compound.

Betamethasone dipropionate is a synthetic corticosteroid.

Betamethasone dipropionate has the chemical name Pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11β,16β), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

Betamethasone dipropionate Structural Formula Illustration

Betamethasone dipropionate is a white to almost white, crystalline powder.

Each gram of Taclonex® Topical Suspension contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, PPG-15 stearyl ether and mineral oil. Taclonex® Topical Suspension is a viscous, nearly odorless, almost clear, colorless to slightly off-white suspension.

What are the possible side effects of betamethasone and calcipotriene (Taclonex, Taclonex Scalp)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using betamethasone and calcipotriene and call your doctor at once if you have any of these serious side effects:

  • severe skin irritation on treated areas;
  • worsened symptoms or no improvement in psoriasis;
  • pus, swelling, redness, increased itching, or other signs of skin infection;
  • confusion, thirst, extreme tiredness, lost appetite, weight...

Read All Potential Side Effects and See Pictures of Taclonex Scalp »

What are the precautions when taking calcipotriene and betamethasone dipropionate topical suspension (Taclonex Scalp)?

Before using this medication, tell your doctor or pharmacist if you are allergic to betamethasone or calcipotriene; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor your medical history, especially of: a certain mineral imbalance (high calcium levels in the blood or urine), thin skin in the area to be treated, liver disease.

If you have a skin infection (such as chickenpox, herpes simplex) or a skin problem other than psoriasis, it should be treated before you start this medication. Betamethasone and other corticosteroid drugs can slow down your body's response to antibiotic drugs and make it more...

Read All Potential Precautions of Taclonex Scalp »

Last reviewed on RxList: 10/29/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Taclonex® Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older.

DOSAGE AND ADMINISTRATION

Usual Dosage and Administration

Apply Taclonex® Topical Suspension to affected areas once daily for up to 8 weeks. Treatment may be discontinued earlier, if cleared.

Instruct patients not to exceed a maximum weekly dose of 100 g.

Important Administration Instructions

Instruct patients to shake bottle prior to using Taclonex® Topical Suspension and to wash their hands after applying the product. Taclonex® Topical Suspension is not for oral, ophthalmic, or intravaginal use.

HOW SUPPLIED

Dosage Forms And Strengths

Topical Suspension, 0.005%/0.064%

Each gram of Taclonex® Topical Suspension contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone). Taclonex® Topical Suspension is a viscous, nearly odorless, almost clear, colorless to slightly off-white suspension.

Storage And Handling

Taclonex® Topical Suspension is a viscous, nearly odorless, almost clear, colorless to slightly off-white suspension. It is available in bottles of: 60 g (NDC 50222-501-06)

Storage

Store between 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F). [See USP controlled room temperature.] Do not refrigerate. Keep the bottle in the outer carton when not in use. The product should be used within six months after it has been opened.

Handling

Shake before use. Keep out of reach of children

Manufactured by: LEO Laboratories Ltd. (LEO Pharma) 285 Cashel Road Dublin 12, Ireland. Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054, USA 1-877-494-4536. Revised: 10/2012

Last reviewed on RxList: 10/29/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directed compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials on the Scalp

The rates of adverse reactions given below were derived from randomized, multicenter, prospective vehicle- and/or active controlled clinical trials in subjects with scalp psoriasis. Subjects applied study product once daily for 8 weeks, and the median weekly dose was 12.6 g. Adverse reactions that occurred in .1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1:

Table 1: Number and Percentage with Adverse Reactions in Scalp Psoriasis Trials (Events Reported by .1% of Subjects and for Which a Relationship is Possible)

  Taclonex® Topical Suspension
N=1,953
Betamethasone dipropionate in vehicle
N=1,214
Calcipotriene in vehicle
N=979
Vehicle
N=173
Event # of subjects (%)
Folliculitis 16 (1%) 12 (1%) 5 (1%) 0 (0%)
Burning sensation of skin 13 (1%) 10 (1%) 29 (3%) 0 (0%)

Other less common adverse reactions ( < 1% but > 0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash. In a 52-week trial, adverse reactions that were reported by > 1% of subjects treated with Taclonex® Topical Suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%).

Clinical Trials on the Body

In randomized, multicenter, prospective vehicle- and/or active controlled clinical trials in subjects with plaque psoriasis on non-scalp areas, subjects applied study product once daily for 8 weeks. A total of 824 subjects were treated with Taclonex® Topical Suspension and the median weekly dose was 22.6 g. There were no adverse reactions that occurred in ≥ 1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle.

Other less common adverse reactions ( < 1% but > 0.1%) were, in decreasing order of incidence: rash and folliculitis.

Last reviewed on RxList: 10/29/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypercalcemia and Hypercalciuria

Hypercalcemia and hypercalciuria have been observed with use of Taclonex® Topical Suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. The incidence of hypercalcemia and hypercalciuria following Taclonex® Topical Suspension treatment of more than 8 weeks has not been evaluated.

Hypothalamic-Pituitary-Adrenal Axis Suppression

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In a trial of 32 subjects treated with both Taclonex® Topical Suspension on the scalp and Taclonex® Ointment on the body, adrenal suppression was identified in 5 of 32 subjects (16%) after 4 weeks of treatment and in 2 of 11 subjects (18%) who continued treatment for 8 weeks. In another trial of 43 subjects treated with Taclonex® Topical Suspension on body (including the scalp in 36 out of 43 subjects) adrenal suppression was identified in 3 out of 43 subjects (7%) after 4 weeks of treatment and in none of the 36 subjects who continued treatment for 8 weeks. [See CLINICAL PHARMACOLOGY]

Evaluation of HPA Axis Suppression

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, attempt to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [See Use in Specific Populations]

Cushing's Syndrome, Hyperglycemia, and Diabetes Mellitus

Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [See Use in Specific Populations]

Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. Do not use on face, axillae, or groin. Do not use if atrophy is present at the treatment site.

Allergic Contact Dermatitis with Topical Corticosteroids

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

Allergic Contact Dermatitis with Topical Calcipotriene

Allergic contact dermatitis has been observed with use of topical calcipotriene. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

Concomitant Skin Infections

Treat concomitant skin infections with an appropriate antimicrobial agent. If the infection persists, discontinue Taclonex® Topical Suspension until the infection has been adequately treated.

Eye Irritation

Avoid eye exposures. Taclonex® Topical Suspension may cause eye irritation.

Risks of Ultraviolet Light Exposures

Patients who apply Taclonex® Topical Suspension to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. Physicians may wish to limit or avoid use of phototherapy in patients who use Taclonex® Topical Suspension.

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use)

Inform patients of the following:

  • This medication is to be used as directed by the physician.
  • Do not use this medication for any disorder other than for which is has been prescribed
  • This medication is for external use only.
  • Avoid contact with the face or eyes. If this medicine gets on face or in eyes, wash area right away.
  • Do not apply Taclonex® Topical Suspension to the scalp in the 12 hours before or after any chemical treatments to the hair. Since hair treatments may involve strong chemicals, talk with physician first.
  • Wash hands after application.
  • If applied to the scalp, do not wash hair or take a bath or shower right after application.
  • Do not bandage or otherwise occlude the treated skin area unless directed by the physician.
  • Instruct patients to report any signs of adverse reactions to their physician.
  • Instruct patients not to use other products containing calcipotriene or a corticosteroid with Taclonex® Topical Suspension without first talking to the physician.
  • Instruct patients who use Taclonex® Topical Suspension to avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10, and 30 mcg/kg/day (corresponding to 9, 30, and 90 mcg/m²/day), no significant changes in tumor incidence were observed when compared to control.

In a study in which albino hairless mice were exposed to both ultra-violet radiation (UVR) and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors.

When betamethasone dipropionate was applied topically to CD-1 mice for up to 24 months at dosages approximating 1.3, 4.2, and 8.5 mcg/kg/day in females, and 1.3, 4.2, and 12.9 mcg/kg/day in males (corresponding to dosages of up to approximately 26 mcg/m²/day and 39 mcg/m²/day, in females and males, respectively), no significant changes in tumor incidence were observed when compared to control.

When betamethasone dipropionate was administered via oral gavage to male and female Sprague Dawley rats for up to 24 months at dosages of 20, 60, and 200 mcg/kg/day (corresponding to dosages of approximately 3, 10, and 30 mcg/m²/day), no significant changes in tumor incidence were observed when compared to control.

Calcipotriene did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, the human lymphocyte chromosome aberration test, or the mouse micronucleus test. Betamethasone dipropionate did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test.

Studies in rats with oral doses of up to 54 mcg/kg/day (324 mcg/m²/day) of calcipotriene indicated no impairment of fertility or general reproductive performance. Studies in male rats at oral doses of up to 200 mcg/kg/day (1200 mcg/m²/day), and in female rats at oral doses of up to 1000 mcg/kg/day (6000 mcg/m²/day), of betamethasone dipropionate indicated no impairment of fertility.

Use In Specific Populations

Pregnancy

Teratogenic Effects - Pregnancy Category C

Animal reproduction studies have not been conducted with Taclonex® Topical Suspension. Taclonex® Topical Suspension contains calcipotriene that has been shown to be fetotoxic and betamethasone dipropionate that has been shown to be teratogenic in animals when given systemically. There are no adequate and well-controlled studies in pregnant women. Taclonex® Topical Suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Teratogenicity studies with calcipotriene were performed by the oral route in rats and rabbits. In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 mcg/kg/day (144 mcg/m²/day); a dosage of 36 mcg/kg/day (432 mcg/m²/day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 mcg/kg/day (324 mcg/m²/day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles were most likely due to the effect of calcipotriene upon calcium metabolism. The estimated maternal and fetal no-adverse effect levels (NOAEL) in the rat (108 mcg/m²/day) and rabbit (48 mcg/m²/day) derived from oral studies are lower than the maximum topical dose of calcipotriene in man (460 mcg/m²/day). Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in mice and rabbits when given by the subcutaneous route at dosages of 156 mcg/kg/day (468 mcg/m²/day) and 2.5 mcg/kg/day (30 mcg/m²/day), respectively. Those dose levels are lower than the maximum topical dose in man (about 5,950 mcg/m²/day). The abnormalities observed included umbilical hernia, exencephaly and cleft palate. Pregnant women were excluded from the clinical studies conducted with Taclonex® Topical Suspension.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Topical Suspension is administered to a nursing woman. The patient should be instructed not to use Taclonex® Topical Suspension on the breast when nursing.

Pediatric Use

Safety and effectiveness of the use of Taclonex® Topical Suspension in pediatric patients have not been studied. Because of a higher ratio of skin surface area to body mass, children under the age of 12 years are at particular risk of systemic adverse effects when they are treated with topical corticosteroids. [See WARNINGS AND PRECAUTIONS] HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Of the total number of subjects in the controlled clinical studies of Taclonex® Topical Suspension in psoriasis vulgaris on non-scalp areas, 124 were 65 years or older, while 36 were 75 years or older. Of the total number of subjects in the controlled clinical studies of Taclonex® Topical Suspension in scalp psoriasis, 334 were 65 years or older, while 84 were 75 years or older.

No overall differences in safety or effectiveness of Taclonex® Topical Suspension were observed between subjects in these age ranges versus younger subjects. All other reported clinical experience has not identified any differences in response between elderly and younger patients.

Unevaluated Uses

Safety and efficacy in patients with known or suspected disorders of calcium metabolism have not been evaluated

Safety and efficacy in patients with known erythrodermic, exfoliative, or pustular psoriasis have not been evaluated

Safety and efficacy in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated

Last reviewed on RxList: 10/29/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Taclonex® Topical Suspension can be absorbed in sufficient amounts to produce systemic effects [See WARNINGS AND PRECAUTIONS].

CONTRAINDICATIONS

None.

Last reviewed on RxList: 10/29/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Taclonex® Topical Suspension combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in psoriasis vulgaris are unknown.

Pharmacodynamics

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression:

HPA axis suppression was evaluated in two trials (Trial A and B) following the application of Taclonex® Topical Suspension. In Trial A, HPA axis suppression was evaluated in adult subjects (N=32) with extensive psoriasis involving at least 30% of the scalp and, in total, 15-30% of the body surface area. Treatment consisted of once daily application of Taclonex® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body for 4 to 8 weeks. Adrenal suppression as indicated by a 30-minute post-stimulation cortisol level ≤ 18 mcg/dL was observed in 5 of 32 subjects (15.6%) after 4 weeks of treatment and in 2 of 11 subjects (18.2%) who continued treatment for 8 weeks.

In Trial B, HPA axis suppression was evaluated in adult subjects (N=43) with extensive psoriasis involving 15-30% of the body surface area (including the scalp). Treatment consisted of once daily application of Taclonex® Topical Suspension to the body (including the scalp in 36 out of 43 subjects) for 4 to 8 weeks. Adrenal suppression as indicated by a 30-minute post-stimulation cortisol level ≤ 18 mcg/dL was observed in 3 out of 43 subjects (7%) after 4 weeks of treatment and in none of the 36 subjects who continued treatment for 8 weeks.

Effects on Calcium Metabolism

In Trial A described above, the effects of once daily application of Taclonex® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body for 4 to 8 weeks on calcium metabolism were also examined. Following once daily application of Taclonex® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body, elevated urinary calcium levels outside the normal range were observed in two subjects (one at 4 weeks and one at 8 weeks).

In Trial B, the effects on calcium metabolism of once daily application of Taclonex® Topical Suspension to 15-30% of the body surface area (including the scalp) for 4 to 8 weeks were also examined. There was no change in mean serum or urinary calcium levels. Elevated urinary calcium levels outside the normal range were observed in two subjects (one at 4 weeks and one at 8 weeks).

Pharmacokinetics

Absorption

Taclonex® Topical Suspension

The systemic effect of Taclonex® Topical Suspension in psoriasis was investigated in Trials A and B described above. In Trial A, the serum levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 and 8 weeks of once daily application of Taclonex® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body. Calcipotriene and betamethasone dipropionate were below the lower limit of quantification in all serum samples of the 34 subjects evaluated.

However, one major metabolite of calcipotriene (MC1080) was quantifiable in 10 of 34 (29.4%) subjects at week 4 and in 5 of 12 (41.7%) subjects at week 8. The major metabolite of betamethasone dipropionate, betamethasone 17-propionate (B17P) was also quantifiable in 19 of 34 (55.9%) subjects at week 4 and 7 of 12 (58.3%) subjects at week 8. The serum concentrations for MC1080 ranged from 20-75 pg/mL. The clinical significance of this finding is unknown.

In Trial B, the plasma levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 weeks of once daily application of Taclonex® Topical Suspension to 15-30% of the body surface area (scalp and non-scalp areas). Calcipotriene and its metabolite MC1080 were below the lower limit of quantification in all plasma samples. Betamethasone dipropionate was quantifiable in 1 sample each taken from 4 of 43 (9.3%) subjects. The metabolite of betamethasone dipropionate (B17P) was quantifiable in 16 of 43 (37.2%) subjects. The plasma concentrations of betamethasone dipropionate ranged from 30.9-63.5 pg/mL and that of its metabolite betamethasone 17-propionate ranged from 30.5-257 pg/mL. The clinical significance of this finding is unknown.

Metabolism

Calcipotriene

Calcipotriene metabolism following systemic uptake is rapid and occurs in the liver. The primary metabolites of calcipotriene are less potent than the parent compound.

Calcipotriene is metabolized to MC1046 (the α,β-unsaturated ketone analog of calcipotriene),which is metabolized further to MC1080 (a saturated ketone analog). MC1080 is the major metabolite in plasma. MC1080 is slowly metabolized to calcitroic acid.

Betamethasone dipropionate

Betamethasone dipropionate is metabolized to betamethasone 17-propionate and betamethasone, including the 6β-hydroxy derivatives of those compounds by hydrolysis. Betamethasone 17-propionate (B17P) is the primary metabolite.

Clinical Studies

Clinical Trials on the Scalp

Two multicenter, randomized, double-blind trials were conducted in subjects with scalp psoriasis. In Trial One, 1,407 subjects were randomized to 1 of 4 treatment groups: Taclonex® Topical Suspension, betamethasone dipropionate in the same vehicle, calcipotriene hydrate in the same vehicle, or the vehicle alone. Trial Two did not include a vehicle arm; 1,280 subjects were randomized to 1 of 3 treatment groups: Taclonex® Topical Suspension, betamethasone dipropionate in the same vehicle, or calcipotriene hydrate in the same vehicle. Both trials enrolled subjects with moderate to very severe scalp psoriasis. The majority of subjects had disease of moderate severity at baseline. Subjects were treated once daily for 8 weeks.

Efficacy was assessed as the proportion of subjects at Week 8 with absent or very mild disease according to the Investigator's Global Assessment of Disease Severity. “Clear” was defined as no evidence of redness, thickness or scaling. “Almost clear” was defined as an overall clinical picture of lesions with the presence of minimal erythema. Table 3 contains the response rates in each of these 2 trials.

Table 2: Percentage of Patients with Clear or Almost Clear Disease According to the Investigator's Global Assessment of Disease Severity in Trials on the Scalp

Trial One Taclonex® Topical Suspension
(N = 494)
Betamethasone Dipropionate in vehicle
(N = 531)
Calcipotriene in vehicle
(N = 256)
Vehicle
(N = 126)
Week 2 55.5% 46.1% 18.4% 9.5%
Week 8 70.0% 63.1% 36.7% 19.8%
Trial Two (N = 512) (N = 517) (N = 251) -
Week 2 47.1% 36.4% 12.7% -
Week 8 67.2% 59.6% 41.0% -

Clinical Trial on the Body

One multicenter, randomized, double-blind trial was conducted in subjects with psoriasis vulgaris on non-scalp areas, excluding face, axillae, and groin. In this trial, 1152 subjects were randomized to 1 of 4 treatment groups: Taclonex® Topical Suspension, betamethasone dipropionate in the same vehicle, calcipotriene hydrate in the same vehicle, or the vehicle alone. The trial enrolled subjects with mild to moderate psoriasis vulgaris. Seventy-eight percent of subjects had disease of moderate severity at baseline. Subjects were treated once daily for 8 weeks.

Efficacy was assessed at Week 4 and Week 8 as the proportion of subjects who were “Clear” or “Almost clear” according to the Investigator's Global Assessment of Disease Severity. Subjects with mild disease at baseline were required to be “Clear” to be considered a success. Table 2 contains the response rates in this trial.

Table 3 : Percentage of Patients with Clear or Almost Clear Disease According to the Investigator's Global Assessment of Disease Severity* in Trial on the Body

  Taclonex® Topical Suspension
(N = 482)
Betamethasone Dipropionate in vehicle
(N = 479)
Calcipotriene in vehicle
(N = 96)
Vehicle
(N= 95)
Week 4 13.3% 12.5% 5.2% 2.1%
Week 8 29.0% 21.5% 14.6% 6.3%
* Subjects with mild disease at baseline were required to be “Clear” to be considered a success.

Last reviewed on RxList: 10/29/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Taclonex®
(TAK-lo-NEKS)
(calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%

Read the Patient Information that comes with Taclonex® Topical Suspension before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Important: Taclonex® Topical Suspension is for use on skin only (topical). Do not get Taclonex® Topical Suspension near or in your mouth, eyes, or vagina.

Another product, Taclonex® Ointment contains the same medicine that is in Taclonex® Topical Suspension and is used to treat psoriasis vulgaris of the skin. If you use both medicines to treat your psoriasis vulgaris, be sure to follow your doctor's directions so that you do not use too much of one or both of these medicines.

What is Taclonex® Topical Suspension?

Taclonex® Topical Suspension is a prescription medicine that is for topical use only. Taclonex® Topical Suspension is used to treat psoriasis vulgaris in people 18 years of age and older.

It is not known if Taclonex® Topical Suspension is safe and effective in children under 18 years of age.

What should I tell my doctor before using Taclonex® Topical Suspension?

Before you use Taclonex® Topical Suspension, tell your doctor if you:

  • have a skin infection on the area affected by psoriasis. Your skin infection should be treated before you start using Taclonex® Topical Suspension
  • have a calcium metabolism disorder
  • have one of the following types of psoriasis:
  • have thinning-skin (atrophy) at the site to be treated.
  • are getting light therapy (phototherapy treatments) for your psoriasis
  • are pregnant or plan to become pregnant. It is not known if Taclonex® Topical Suspension will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Taclonex® Topical Suspension passes into your breast milk. You should not use Taclonex® Topical suspension on your breast if you breastfeed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Especially tell your doctor if you use

  • other corticosteroid medicines
  • other medicines for your psoriasis.

Know the medicine you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use Taclonex® Topical Suspension?

  • Use Taclonex® Topical Suspension exactly as your doctor tells you to use it.
  • Your doctor should tell you how much Taclonex® Topical Suspension to use and where to use it.
  • Do not use more than the maximum recommended weekly amount of 100 grams of medicines containing calcipotriene (one of the active ingredients of Taclonex® Topical Suspension).
  • Apply Taclonex® Topical Suspension to affected areas on the skin 1 time a day for up to 8 weeks. Treatment may be discontinued earlier if cleared.
  • Shake the Taclonex® Topical Suspension bottle before you use it.
  • Do not apply Taclonex® Topical Suspension to the scalp in the 12 hours before or after any chemical treatments to your hair. Since hair treatments may involve strong chemicals, talk with your doctor first.
  • If you accidentally get Taclonex® Topical Suspension on your face or in your eyes wash the area with water right away.
  • Wash your hands after using Taclonex® Topical Suspension.
  • Do not wash your hair or take a bath or shower right after applying Taclonex® Topical Suspension as the medicine will not work as well to treat your psoriasis.
  • Do not bandage or cover the treated skin area.

What should I avoid while using Taclonex® Topical Suspension?

Avoid spending a long time in sunlight. Avoid tanning booths and sun lamps. Use sunscreen and wear a hat and clothes that cover treated areas if you have to be in the sunlight. Talk to your doctor if you get a sunburn.

What are the possible side effects of Taclonex® Topical Suspension?

Taclonex® Topical Suspension may cause serious side effects, including:

  • too much calcium in your blood or urine
  • adrenal gland problems
    Your doctor may do blood and urine tests to check your calcium levels and adrenal gland function while you are using Taclonex® Topical Suspension.
  • skin problems such as:
    • thinning of your skin
    • burning
    • inflammation
    • itching
    • irritation
    • dryness
    • changes in skin color
    • redness
    • infection
    • raised bumps on your skin
  • eye irritation if you accidently get Taclonex® Topical Suspension in your eyes.

The most common side effects of Taclonex® Topical Suspension are inflamed hair pores (folliculitis) and skin burning.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Taclonex® Topical Suspension. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store Taclonex® Topical Suspension?

  • Store Taclonex® Topical Suspension between 68°F to 77°F (20°C to 25°C).
  • Do not refrigerate Taclonex® Topical Suspension.
  • Keep the bottle in the outer carton when not in use.

Use Taclonex® Topical Suspension within six months after it has been opened

Keep Taclonex® Topical Suspension and all medicines out of the reach of children.

General information about Taclonex® Topical Suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Taclonex® Topical Suspension for a condition for which it was not prescribed. Do not give Taclonex® Topical Suspension to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Taclonex® Topical Suspension. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Taclonex® Topical Suspension that is written for health professionals.

For more information, go to www.taclonex.com or call 1-877-494-4536.

What are the ingredients in Taclonex® Topical Suspension?

Active ingredients: calcipotriene hydrate and betamethasone dipropionate.

Inactive ingredients: hydrogenated castor oil, PPG-15 stearyl ether and mineral oil.

Instructions for Use

Taclonex
(TAK-lo-NEKS)
(calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%

Important: For skin use only. Do not get Taclonex® Topical Suspension near or in your mouth, eyes or vagina.

Read these Instructions for Use before you start using Taclonex® Topical Suspension and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

How to apply Taclonex® Topical Suspension to your body:

Follow your doctor's instructions of how much Taclonex® Topical Suspension to use and where to use it. Apply Taclonex® Topical Suspension directly to areas affected by psoriasis and gently rub in. Wash your hands after applying Taclonex® Topical Suspension.

How to apply Taclonex® Topical Suspension to your scalp:

  • You do not need to wash your hair before you apply Taclonex® Topical Suspension.

Shake bottle before use. Remove the cap.

Shake bottle before use - Illustration

It may help to part your hair before you use Taclonex® Topical Suspension.

Part your hair before you use - Illustration

Apply a drop of Taclonex® Topical Suspension to your fingertip.

Apply a drop of Taclonex® Topical Suspension to your fingertip - Illustration

Apply directly to scalp areas affected by psoriasis and gently rub in Taclonex® Topical Suspension.

Gently rub in - Illustration

  • Do not wash your hair right after you apply Taclonex® Topical Suspension.
  • Wash your hands after applying Taclonex® Topical Suspension.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 10/29/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Taclonex®
(TAK-lo-NEKS)
(calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%

Read the Patient Information that comes with Taclonex® Topical Suspension before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Important: Taclonex® Topical Suspension is for use on skin only (topical). Do not get Taclonex® Topical Suspension near or in your mouth, eyes, or vagina.

Another product, Taclonex® Ointment contains the same medicine that is in Taclonex® Topical Suspension and is used to treat psoriasis vulgaris of the skin. If you use both medicines to treat your psoriasis vulgaris, be sure to follow your doctor's directions so that you do not use too much of one or both of these medicines.

What is Taclonex® Topical Suspension?

Taclonex® Topical Suspension is a prescription medicine that is for topical use only. Taclonex® Topical Suspension is used to treat psoriasis vulgaris in people 18 years of age and older.

It is not known if Taclonex® Topical Suspension is safe and effective in children under 18 years of age.

What should I tell my doctor before using Taclonex® Topical Suspension?

Before you use Taclonex® Topical Suspension, tell your doctor if you:

  • have a skin infection on the area affected by psoriasis. Your skin infection should be treated before you start using Taclonex® Topical Suspension
  • have a calcium metabolism disorder
  • have one of the following types of psoriasis:
  • have thinning-skin (atrophy) at the site to be treated.
  • are getting light therapy (phototherapy treatments) for your psoriasis
  • are pregnant or plan to become pregnant. It is not known if Taclonex® Topical Suspension will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Taclonex® Topical Suspension passes into your breast milk. You should not use Taclonex® Topical suspension on your breast if you breastfeed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Especially tell your doctor if you use

  • other corticosteroid medicines
  • other medicines for your psoriasis.

Know the medicine you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use Taclonex® Topical Suspension?

  • Use Taclonex® Topical Suspension exactly as your doctor tells you to use it.
  • Your doctor should tell you how much Taclonex® Topical Suspension to use and where to use it.
  • Do not use more than the maximum recommended weekly amount of 100 grams of medicines containing calcipotriene (one of the active ingredients of Taclonex® Topical Suspension).
  • Apply Taclonex® Topical Suspension to affected areas on the skin 1 time a day for up to 8 weeks. Treatment may be discontinued earlier if cleared.
  • Shake the Taclonex® Topical Suspension bottle before you use it.
  • Do not apply Taclonex® Topical Suspension to the scalp in the 12 hours before or after any chemical treatments to your hair. Since hair treatments may involve strong chemicals, talk with your doctor first.
  • If you accidentally get Taclonex® Topical Suspension on your face or in your eyes wash the area with water right away.
  • Wash your hands after using Taclonex® Topical Suspension.
  • Do not wash your hair or take a bath or shower right after applying Taclonex® Topical Suspension as the medicine will not work as well to treat your psoriasis.
  • Do not bandage or cover the treated skin area.

What should I avoid while using Taclonex® Topical Suspension?

Avoid spending a long time in sunlight. Avoid tanning booths and sun lamps. Use sunscreen and wear a hat and clothes that cover treated areas if you have to be in the sunlight. Talk to your doctor if you get a sunburn.

What are the possible side effects of Taclonex® Topical Suspension?

Taclonex® Topical Suspension may cause serious side effects, including:

  • too much calcium in your blood or urine
  • adrenal gland problems
    Your doctor may do blood and urine tests to check your calcium levels and adrenal gland function while you are using Taclonex® Topical Suspension.
  • skin problems such as:
    • thinning of your skin
    • burning
    • inflammation
    • itching
    • irritation
    • dryness
    • changes in skin color
    • redness
    • infection
    • raised bumps on your skin
  • eye irritation if you accidently get Taclonex® Topical Suspension in your eyes.

The most common side effects of Taclonex® Topical Suspension are inflamed hair pores (folliculitis) and skin burning.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Taclonex® Topical Suspension. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store Taclonex® Topical Suspension?

  • Store Taclonex® Topical Suspension between 68°F to 77°F (20°C to 25°C).
  • Do not refrigerate Taclonex® Topical Suspension.
  • Keep the bottle in the outer carton when not in use.

Use Taclonex® Topical Suspension within six months after it has been opened

Keep Taclonex® Topical Suspension and all medicines out of the reach of children.

General information about Taclonex® Topical Suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Taclonex® Topical Suspension for a condition for which it was not prescribed. Do not give Taclonex® Topical Suspension to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Taclonex® Topical Suspension. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Taclonex® Topical Suspension that is written for health professionals.

For more information, go to www.taclonex.com or call 1-877-494-4536.

What are the ingredients in Taclonex® Topical Suspension?

Active ingredients: calcipotriene hydrate and betamethasone dipropionate.

Inactive ingredients: hydrogenated castor oil, PPG-15 stearyl ether and mineral oil.

Instructions for Use

Taclonex
(TAK-lo-NEKS)
(calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%

Important: For skin use only. Do not get Taclonex® Topical Suspension near or in your mouth, eyes or vagina.

Read these Instructions for Use before you start using Taclonex® Topical Suspension and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

How to apply Taclonex® Topical Suspension to your body:

Follow your doctor's instructions of how much Taclonex® Topical Suspension to use and where to use it. Apply Taclonex® Topical Suspension directly to areas affected by psoriasis and gently rub in. Wash your hands after applying Taclonex® Topical Suspension.

How to apply Taclonex® Topical Suspension to your scalp:

  • You do not need to wash your hair before you apply Taclonex® Topical Suspension.

Shake bottle before use. Remove the cap.

Shake bottle before use - Illustration

It may help to part your hair before you use Taclonex® Topical Suspension.

Part your hair before you use - Illustration

Apply a drop of Taclonex® Topical Suspension to your fingertip.

Apply a drop of Taclonex® Topical Suspension to your fingertip - Illustration

Apply directly to scalp areas affected by psoriasis and gently rub in Taclonex® Topical Suspension.

Gently rub in - Illustration

  • Do not wash your hair right after you apply Taclonex® Topical Suspension.
  • Wash your hands after applying Taclonex® Topical Suspension.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 10/29/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Taclonex Scalp Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

BETAMETHASONE/CALCIPOTRIENE (CALCIPOTRIOL) SCALP - TOPICAL

(BAY-ta-METH-a-sone/KAL-si-poe-TRYE-een/KAL-si-poe-TRYE-ol)

COMMON BRAND NAME(S): Taclonex Scalp

USES: This product contains 2 drugs (betamethasone and calcipotriene) and is used to treat psoriasis of the scalp. Betamethasone is a very strong corticosteroid drug that helps decrease the swelling, redness, and itching of the skin that occurs with this condition. Calcipotriene, which is also known as calcipotriol in other countries, is a form of vitamin D. It works by slowing down the growth of skin cells so that they do not build up into thickened, scaly skin patches.

This medication should not be used if you have certain types of psoriasis (skin patches with pus-filled blisters, psoriasis with intense redness/shedding/oozing). Consult your doctor for more information.

This product is not recommended for use in children because they may be at an increased risk for side effects. See also Side Effects and Precautions sections.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is for use on the scalp only. Do not apply this product 12 hours before or after any chemical treatments to your hair. Shake the bottle well before use. Part your hair, apply the product only to the affected area(s) of the scalp, and gently rub in, usually once daily or as directed by your doctor. Wash your hands after using, but do not wash your hair right after applying this product. Avoid getting any medication in the eyes or ears. If this occurs, immediately rinse with plenty of water. Do not apply this product to the face, underarms, or groin area.

Do not use this medication more often or for longer than directed. Do not use more than 100 grams of this product a week unless directed and closely monitored by your doctor. Do not bandage, wrap, or cover the treated area unless your doctor instructs you to do so. Do not use this product on large areas of damaged skin. Following these instructions helps to reduce your risk of side effects.

Tell your doctor if your condition does not improve or if it worsens. It may take up to 2 weeks to see any improvement.

Disclaimer

Taclonex Scalp Consumer (continued)

SIDE EFFECTS: Itching, burning, redness, or irritation of the skin may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: skin thinning/discoloration/"stretch marks", swelling/inflammation of the hair pores (folliculitis), worsening of psoriasis.

This medication may infrequently cause an increase in the level of calcium in your blood or urine. Tell your doctor immediately if you notice any of the following unlikely but serious side effects: mental/mood changes, unexplained constipation, pink/bloody urine, painful urination.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Taclonex Scalp (calcipotriene and betamethasone dipropionate topical suspension) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to betamethasone or calcipotriene; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor your medical history, especially of: a certain mineral imbalance (high calcium levels in the blood or urine), thin skin in the area to be treated, liver disease.

If you have a skin infection (such as chickenpox, herpes simplex) or a skin problem other than psoriasis, it should be treated before you start this medication. Betamethasone and other corticosteroid drugs can slow down your body's response to antibiotic drugs and make it more difficult to clear an infection.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Your doctor may direct you to limit or avoid phototherapy while you use this product. Discuss this further with your doctor.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the skin. Consult your doctor before breast-feeding.

Disclaimer

Taclonex Scalp Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other corticosteroid drugs (such as hydrocortisone, prednisone), other products containing calcipotriene.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor or pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.

Try to identify and reduce the triggers that may worsen your psoriasis (such as stress, skin injury, smoking). Discuss with your doctor additional ways to control symptoms.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted.

Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised February 2011. Copyright(c) 2011 First Databank, Inc.

Taclonex Scalp Patient Information Including Side Effects

Brand Names: Taclonex, Taclonex Scalp

Generic Name: betamethasone and calcipotriene (topical) (Pronunciation: BAY ta METH a sone and KAL si poe TRYE een)

What is betamethasone and calcipotriene (Taclonex Scalp)?

Betamethasone is a topical corticosteroid. It reduces swelling, relieves itching, and constricts blood vessels.

Calcipotriene is a form of vitamin D. It works by decreasing the rate of skin cell reproduction.

Betamethasone and calcipotriene is a combination drug used to treat psoriasis vulgaris.

Betamethasone and calcipotriene may also be used for other purposes not listed in this medication guide.

What are the possible side effects of betamethasone and calcipotriene (Taclonex Scalp)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using betamethasone and calcipotriene and call your doctor at once if you have any of these serious side effects:

  • severe skin irritation on treated areas;
  • worsened symptoms or no improvement in psoriasis;
  • pus, swelling, redness, increased itching, or other signs of skin infection;
  • confusion, thirst, extreme tiredness, lost appetite, weight loss;
  • adrenal insufficiency--nausea, vomiting, lost appetite, tiredness, trouble breathing, joint/muscle pain, feeling light-headed, fainting;
  • Cushing syndrome--weight gain (especially in your face), thinning muscles in your arms or legs, easy bruising, thinning skin, acne, increased facial hair, darkened skin; or
  • high blood sugar (hyperglycemia)--increased urination and thirst, nausea, vomiting.

Less serious side effects may include:

  • burning or mild itching;
  • red or scaly rash;
  • swollen hair follicles; or
  • changes in the color of treated skin areas.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Taclonex Scalp (calcipotriene and betamethasone dipropionate topical suspension) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about betamethasone and calcipotriene (Taclonex Scalp)?

Use this medication exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Before using betamethasone and calcipotriene, tell your doctor if you are pregnant or breast-feeding.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs that can affect betamethasone and calcipotriene. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

Side Effects Centers

Taclonex Scalp Patient Information including How Should I Take

What should I discuss with my healthcare provider before using betamethasone and calcipotriene (Taclonex Scalp)?

Before using this medication, tell your doctor if you have:

  • low or high levels of calcium in your blood;
  • liver or kidney disease;
  • severe forms of psoriasis (with pus, skin peeling, severe redness); or
  • a skin infection.

If you have any of these conditions, you may not be able to use betamethasone and calcipotriene, or you may need a dose adjustment or special tests during treatment.

Tell your doctor if you are receiving UV light treatments (phototherapy) for your psoriasis.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using betamethasone and calcipotriene, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known if betamethasone and calcipotriene pass into breast milk or if this medicine could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

This medicine should not be used on a child.

How should I use betamethasone and calcipotriene (Taclonex Scalp)?

Use betamethasone and calcipotriene exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after applying this medicine.

Betamethasone and calcipotriene topical is for use on the skin only. However, do not apply the medicine to your face, underarms, or groin (genital area).

Shake the liquid form of this medication before using it.

Apply a thin layer of the medication and rub it in completely.

Do not cover treated skin areas with a bandage or tight clothing, unless your doctor has told you to.

Do not use betamethasone and calcipotriene for longer than 4 weeks unless your doctor has told you to.

While you are using this medication, your blood and urine may need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Store this medicine at room temperature away from moisture and heat. Keep the tube capped and tightly closed when not in use.

Side Effects Centers

Taclonex Scalp Patient Information including If I Miss a Dose

What happens if I miss a dose (Taclonex Scalp)?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Taclonex Scalp)?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it.

Overdose symptoms may include nausea, vomiting, lost appetite, tiredness, trouble breathing, joint/muscle pain, feeling light-headed, or fainting.

What should I avoid while using betamethasone and calcipotriene (Taclonex Scalp)?

Avoid applying this medicine to more than one-third of your skin surface at any one time.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Betamethasone and calcipotriene topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use this medicine on sunburned, windburned, dry, chapped, irritated, or broken skin; or on open wounds. Also avoid using this medication in wounds or on areas of infection. Wait until these conditions have healed before using betamethasone and calcipotriene topical.

What other drugs will affect betamethasone and calcipotriene (Taclonex Scalp)?

Before using betamethasone and calcipotriene, tell your doctor if you are using any other steroid medicines, or other medicines to treat psoriasis.

There may be other drugs that can interact with betamethasone and calcipotriene. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has more information about betamethasone and calcipotriene topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.05. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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